Heart clot detection gets a High-Tech upgrade: new PET scan tested in rare heart disease
NCT ID NCT07560306
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tests a new PET scan that uses a special tracer to find blood clots inside the heart. It involves 20 people with cardiac amyloidosis and atrial fibrillation. The goal is to see if this scan can spot clots better than current methods, which could help prevent strokes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [64Cu]FBP8 (a radioactive tracer that binds to fibrin, a protein in blood clots)
- What this could lead to
- If successful, this could provide a non-invasive way to detect dangerous heart clots early, potentially reducing stroke risk in people with cardiac amyloidosis.
- What could go wrong
- This is a small pilot study with only 20 participants, so results may not apply to everyone. The new imaging method may not be more accurate than current standard tests.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have the ability to give written informed consent; * History of amyloid cardiomyopathy (ATTR-CM or AL-CM); * History of AF or AFL; * Retrospective enrollment: TEE to evaluate LAA within the previous 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anticoagulation regimen, then it is unlikely that a new thrombus will develop in the LAA within the next 14 days. Likewise, if a patient not taking any anticoagulation has a thrombus in the LAA, then it is unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient remains off anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET/MR imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard; * Prospective: TEE to evaluate LAA thrombus scheduled in upcoming 14 days; Exclusion Criteria: * Electrical implants such as cardiac pacemaker/defibrillator, perfusion pump, direct brain stimulator; * Pregnancy or breastfeeding (a negative quantitative serum or urine hCG pregnancy test is required for females having child-bearing potential before the subject can participate); * Claustrophobia; * Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months); * Unable to lie comfortably on a bed inside the PET/MR scanner; * Subjects under direct or indirect (i.e., same department as PIs) supervision of the principal investigator; * Body weight over the weight limit for the moving table (\> 300 lbs for the MR table); * Metallic or electric implants contraindicated for PET/MR scanning; * Stroke, myocardial infarction, cardiac or major surgery within the last 3 months; * History of LAA ligation/exclusion or presence of a LAA occlusion device; * History of syncope within the last 6 weeks; * Heart rate persistently \>120 bpm or persistently \<50 bpm; * Daytime pauses \>3 seconds; * Lack of a prior transthoracic echocardiogram within the previous 6 months; * Does not have the ability to give written informed consent; * Determined by the investigator(s) to be clinically unsuitable for the study (e.g., based on screening visit and/or during study procedures);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can AI read fused PET and MRI scans to forecast survival in a rare heart disease?
- Can a single scan reveal hidden amyloid deposits across the body?
- Heart ultrasound may spot a rare heart disease earlier
- A sharper eye on amyloid: could quantitative scans revolutionize cardiac monitoring?
- Can a new PET tracer light up amyloid in the heart?
- Liver clues: a new way to stage heart amyloidosis?